The present invention relates to medical equipment, and, more particularly, to surgical instruments for stitching organs with the aid of metal staples. The proposed instrument is designed for stitching both hollow organs and solid organs and tissues in the end-to-end, end-to-side and side-to-side methods, with the working part of the instrument being disposed exteriorly of the organs being stitched.
The proposed instrument may be employed, inter alia, for applying anastomoses onto digestive canal organs, for instance, intestinal anastomoses.
It is known in the art to employ an instrument for stitching organs with the aid of metal staples in the end-to-end, end-to-side and side-to-side methods, with the working part of the instrument disposed exteriorly of the organs being stitched, which is designed for applying intestinal anastomoses.
This known instrument incorporates two interconnected clamps, each of the clamps having two jaws for clinching and fixing the organs to be stitched. The clamps are pivotally interconnected at one of their ends, the joint line of the jaws of each of the clamps being perpendicular to the joint line of the clamps. In the closed condition of the clamps, the butt surfaces of the clamps adjoin each other, i.e. the clamps are so interconnected that there is no clearance between the aligned paired jaws of different clamps.
The clamp jaws mount a means for grasping and fixing the walls of the organs to be stitched with toothed plates, magazines with slots for staples and pushers for forcing the staples out of the magazines, dies for bending the staples, as well as a device for aligning the organs to be stitched longitudinally with respect to the jaws.
The means for grasping the walls of the organs to be stitched provided in the known instrument comprises two draw-out toothed plates mounted in recesses provided in each jaw of the clamps, a cover for fastening the toothed plates to the jaws, and a drive means disposed in said jaw recess and serving to draw the toothed plates out of the jaws and to displace the toothed plates one relative to the other.
The toothed plates adjoin each other by way of the lateral surfaces thereof and in their initial position are fully recessed in the clamp jaws. The teeth of the plates are formed as cooperating pairs of fixing needles spaced at equal intervals along the longitudinal edges of the plates and curved in such a manner that the tips of the needles, or claws, of one plate are directed towards the tips of the claws of the other plate.
The plates with the claws have inclined slots of equal length formed therein, and the inclined slots of one of the plates terminate in longitudinal slots whose length corresponds to the distance between the tips of the paired curved claws in their initial position. The length of the plate with the inclined and longitudinal slots is equal to the length of the recess formed in the jaw, and this plate can move laterally with respect to the jaw.
The length of the plate having only inclined slots is smaller than that of the recess, and this latter plate can move both laterally and longitudinally with respect to the jaw. The drive of the plates with the fixing claws is provided with projections entering the slots of both plates, as well as with a handle for manipulating said drive.
The drive, and accordingly the projections thereof, occupies either one of two extreme positions relative to the plates with the claws; with the drive set to one, initial, extreme position, the tips of the paired curved claws are set apart and recessed in the clamp jaw, whereas, with the drive set to the other position, the tips of the claws are joined and project from the jaw towards the joint line of the clamp jaws.
With the drive of the plates set to the latter position, the jointed claws grasp and fix the walls of the organ to be stitched.
In the known instrument, the working part of the clamp jaws which carries the means for grasping the walls of the organs to be stitched, as well as the magazines and the dies is formed as part of a cylinder. A magazine is slidably mounted in cylindrical guides on the cylindrical surface of one jaw of each clamp, whereas on the cylindrical surface of the other jaw of the clamp there is mounted a die, which magazine and die cooperate, while stitching organs and after the clamps have been closed, with the die and magazine, respectively, mounted on the paired jaws of the other clamp. The magazines and dies are able to rotate about the jaws of the clamps to be set to either one of two extreme positions. In one extreme position, viz. the working position, the magazine and the die of the jaws of the joined clamps are aligned for stitching and disposed between the butt surfaces of the clamp jaws. In the working position, the butt surfaces of the aligned and coacting magazines and dies are disposed in parallel relationship at a certain distance corresponding to the mean of the possible thicknesses of the tissues being stitched, the slots for the staples of the magazine and the recesses for bending the staples of the dies being directed towards one another.
In the other, initial, position, the cooperating magazine and die are withdrawn from the zone between the butt surfaces of the clamp jaws, and the butt surfaces of the magazine and the die are in angular relationship.
The magazine and the die of the paired jaws of the clamps are transferred from their initial position to the working position with the aid of revolving cams disposed on the jaws of one of the clamps and, after the clamps have been joined, acting on the projections rigidly coupled with the magazine and the die.
The design features of the known instrument provide for the following characteristic arrangements of the functional members of the instrument corresponding to the various characteristic stages of surgical procedure.
As the organs to be stitched are gripped between the jaws of the clamps, the plates with the fixing claws are fully recessed in the clamp jaws, the paired fixing claws are set apart, and the magazine and the die set to their initial position are fully withdrawn from the zone between the butt surfaces of the clamp jaws.
As the walls of the organs being stitched are fixed, the fixing claws of the plates of the means for grasping and fixing the organ walls project beyond the butt surfaces of the clamp jaws and are disposed in the zone between these surfaces, the paired fixing claws being closed. The magazine and the die of the clamp are in their initial position.
While stitching one of the semiperimeters of the aligned walls of the organs, the clamps are joined together, and the joined paired jaws of the clamps are set a certain distance apart. The aligned magazine and die of one pair of the clamp jaws, which is used to stitch the wall semiperimeter, are disposed in their working position between the butt surfaces of the somewhat set-apart paired jaws of the clamps and between the tips of the fixing claws of the clamp jaws, the distance between the magazine and the die being far smaller than the distance between the fixing claws of this joined pair of jaws of different clamps. The magazine and the die of the second pair of jaws of the clamps are disposed in their initial position.
The magazine of the known instrument is formed as a case of intricate spatial configuration with an interior cylindrical surface rotating with respect to the cylindrical surface of the clamp jaw. The case is provided with slots for the staples whereinto sectional pushers are fitted. As the surgeon's fingers manipulate each section of the pushers, 3 to 4 staples are simultaneously forced out of the magazine. The base of the pusher section in the initial position protrudes beyond the magazine, so that, to prevent accidental movement of the pushers and accidental forcing of the staples out of the magazine, the latter is provided with a guard lock which fixes the pushers in the initial position. To enable stitching, the guard lock must be disengaged from the pushers. Just as the drive of the plates with the fixing claws of the means for grasping the walls of the organs to be stitched, the pusher guard lock is formed as plates with a bent end serving as a handle. The handles of the guard lock and of the drive-similar in design and appearance, are disposed on the clamp jaws next to each other.
The die of the known instrument, just as the magazine, has an interior cylindrical surface and is so connected with the clamp jaw as to be able to execute a rotary motion with respect to the cylindrical surface of the jaw.
The magazine and the die of each clamp are provided with cam projections rigidly coupled therewith. These cam projections are designed for setting the clamp jaws apart as the magazine or the die secured to one of the clamp jaws is turned into its working position.
While this turn is being executed, the cam projections come to rest against the surface of the second clamp jaw, driving the jaws apart.
The magazines and the dies are provided with no rotary movement limiter as far as the jaws are concerned; hence, they can be freely removed from their cylindrical guides.
To ensure accurate alignment of the magazines and the dies during stitching, the butt surfaces of one of the clamps are provided with blind holes in the middle portion of the jaws, which blind holes cooperate with pins rigidly secured to the butt surfaces of the other clamp, fixing the paired clamp jaws in a closed condition.
The known instrument is manipulated in the same way whether employed for stitching organs in the end-to-end, side-to-side or end-to-side methods, for which reason its operation will be described only for the case of end-to-end stitching.
Prior to operation, the plates with the fixing claws of the means for grasping and fixing the walls of the organs to be stitched, as well as the magazines and the dies of the clamps must be set to the initial position, and the pushers must be immobilized in the initial position with the aid of the guard lock.
One of the organ ends having the largest semiperimeter is gripped between the jaws of one of the clamps within the limits of the scale of the device for the alignment of the organs being stitched in a longitudinal direction relative to the jaws. Moving the handles of the drives of the plates with the fixing claws of the means for grasping and fixing the walls of the organs being stitched, the drive projections are brought to bear on the slots of the plates with the fixing needles, driving them clear out of the clamp jaws and displacing them one relative to the other. While this operation is being effected, the tips of the paired claws transfix the walls of the organs and then move to meet one another, grasping the tissues in nodes. The organ part to be excised is cut off along the jaws of the former clamp.
Corresponding to the position of the organ gripped and fixed by the jaws of the first clamp by its scale, the second end or the organ to be stitched is positioned between the jaws of the second clamp by its scale. If its semiperimeter is less in cross section than that of the first end being stitched, it is so turned between the jaws of the clamp that the edges of the semiperimeter at the point where the organ is grasped lie precisely between the graduation notches on the scale corresponding to the position of the semiperimeter of the first end of the grasped organ relative to the graduation notches on the scale of the first clamp. After the walls of the second end of the organ being stitched have been fixed in a procedure identical to that used for the first end, the part of the organ that is to be excised is cut off.
Then the two clamps are brought together and fixed so that the butt surfaces of the clamps are in contact, and the sections of the semiperimeters of the clamped and fixed organ ends come to be mutually aligned.
By turning the rotary cams through 90.degree., the magazine and the die of one pair of joined clamp jaws are transferred from the initial position to the working position. The cam projections of the magazine and the dies cooperate in the process with the surfaces of the second pair of clamp jaws to set the pairs of joined jaws a certain distance apart. At this instant, the fixing claws immobilize the edges of the walls of the aligned organs relative to the set-apart paired jaws, and the magazine and the die turn, acting on the outer walls of the organs being stitched which are disposed, relative to the fixing claws, on the side opposite to the clamp joint line, and bringing into contact the inner surfaces of the walls of the organs being stitched.
With the magazine and the die set to their working position, one semiperimeter of the walls of the organs being stitched can be sutured. In this position, each edge of the walls being stitched is bent as an S-shaped loop.
In order to effect the stitching the surgeon manipulates the sectional pusher guard lock handle to disengage it from the pushers, thus setting them free. Pressing with his fingers on each pusher section in succession, the surgeon forces the staples from the magazine and stitches one semiperimeter of the walls of the organs being stitched. This stitching stage over, the cam is turned at 90.degree. to be returned to the initial position, after which the magazine and die projections are rotated about the joined jaws to return the magazine and the die to their initial position.
In order to stitch the second semiperimeter of the intestinal walls, the cam of the second pair of joined jaws disposed beneath the organs being stitched is turned at 90.degree., after which all of the manipulations used in the suturing of the first semiperimeter of the walls being stitched are repeated.
Having stitched both semiperimeters of the organ walls, the drives of the means for grasping the organ walls are reset, the paired fixing claws being first set apart and recessed in the appropriate depressions formed in the clamp jaws. The locking hooks coupling the jaws of the joined clamps are turned and the upper pairs of clamp jaws are drawn away from the lower pairs of clamp jaws disposed beneath the sutured ends of the intestine in the space between the mesenteries of both stitched parts, after which the lower pairs of jaws are withdrawn from beneath the stitched intestine.
The organ stitching operation by use of the prior art instrument involves about 30 strictly sequenced manipulations, with any violation of the operation sequence resulting in a faulty anastomosis.
While stitching organs in the end-to-side method by use of the prior art instrument, first the end of one of the organs to be stitched is clinched and fixed between the jaws of one of the clamps, after which the side of the other organ to be stitched is clinched and fixed between the jaws of the other clamp in accordance with the size and position of said organ end as indicated on the scales of the device for mutually aligning the organs to be stitched in a longitudinal direction with respect to the jaws.
When stitching organs in the side-to-side method by use of the prior art instrument, the side portions of the organs to be stitched are clinched by the scales of both clamps and fixed in such a way that their position with respect to the paired clamp jaws being aligned exactly matches the size of the side anastomosis preset by the surgeon.
Barring the foregoing specific features, the instrument is handled while stitching organs in the end-to-side and side-to-side methods actually in the same way as while applying anastomoses in the end-to-end method.
The principal disadvantage of the prior art surgical instrument for stitching organs with the aid of metal staples consists in that the toothed plates of the means for grasping and fixing the walls of the organs being stitched are built into the clamp jaws, are made on the draw-out principle and secured with the aid of covers; the claws of the plates are positioned, in the course of stitching, between the butt surfaces of the clamp jaws, on the one hand, and the rotatable magazines and dies set to their working position, on the other; and the distance between the claws of the plates of the joined pairs of clamp jaws largely exceeds the stitching clearance between the butt surfaces of the magazine and the die joined for stitching.
Owing to this, the plate claws are disposed a considerable distance from the staple suture applied and hence twist the fixed walls of the organs being stitched in an S-shaped loop, resulting in a sizeable lip (the distance from the suture line to the organ wall section) of the anastomosis when stitching hollow organs. This condition hampers tissue regeneration and gives rise to a large bead at the point of organ union after the second row of the suture is applied while stitching the digestive canal organs, the second row of the suture being applied manually.
The foregoing disadvantage is prohibitive to stitching solid organs.
Furthermore, the prior art instrument lacks operating reliability, entailing a high risk of leaving unstitched organ portions or placing poor-quality sutures.
Thus, in particular, the magazines and the dies rotating about the cylindrical guides of the jaws are unreliably fixed in the working position with the aid of the rotary cams, with the result that in the course of stitching the butt surfaces of the magazine and the die are disengaged one from the other and assume an angular relationship, and the tips of the staples being ejected from the magazines fail to enter the respective recesses formed in the dies.
As a result, the U-shaped staples transfix the walls of the organs but fail to stitch them.
Equally unreliable are the sectional pushers manipulated directly by the surgeon's fingers. Owing to the large overall deforming force of several staples, as well as to the possible jamming and sticking of the sectional pushers, the staples may fail to emerge clear of the magazine, resulting in poor connection of the walls of the organs being stitched, lack of tissue haemostasis and suture tightness.
Sometimes the prior art instrument cannot be taken off the sutured organs without additionally injuring them. The grasping of the organ walls after stitching while withdrawing the instrument from the surgery wound is due to the fact that the claws of the plates of the means for grasping the organ walls are formed as curved members directed towards one another. After stitching and disengagement of the claws of one plate from those of the other plate, the claws are retracted into the narrow recess formed in the clamp jaws, drawing in the tissues they cling to. The danger of the disengaged claws gripping tissues is all the more real since the claws of one of the plates point in the direction of withdrawal of the instrument from the surgery wound.
The prior art instrument is difficult to handle and surgeons have to spend a lot of time and effort to master it, for the stitching operation involves as many as about 30 manipulations sequenced in a definite order. Violation of this sequence and possible instrument handling mistakes due to the design drawbacks result in non-stitching incidents or poor-quality sutures. Thus, the design of the prior art instrument allows the clamps to be joined and the rotary magazines and dies to be set to the stitching position while the organ walls are still unfixed, so that all of the subsequent stitching manipulations result in a defective suture, violation of the sterility requirements and, hence, attempts to repeat the stitching operation.
The operation may become septic and the suture may be defective also due to the fact that in the prior art instrument the handle of the pusher guard lock, preventing accidental forcing of the staples out of the magazine, and the handle of the drive of the toothed plates of the means for grasping and fixing the walls of the organs being stitched are disposed side by side, being similar in design and shape. Consequently, after the magazine and the die have been set to their working position for stitching the semiperimeter of the organ walls, the surgeon is liable to confuse the handles and, instead of manipulating the handle of the pusher guard lock, to mistakenly actuate the handle of the drives of the plates of the means for fixing the organ walls, releasing the latter, with the result that the aligned edges of the organ walls will slip from the zone between the magazine and the die.
The clamp jaws of the prior art instrument have a large cross-section attributable to the draw-out design of the plates of the means for grasping and fixing the walls of the organs being stitched, as well as to the use of awkward rotary magazines and dies rotating about the cylindrical surface of the clamp jaws. In consequence of this, the prior art instrument is functionally limited in use; thus, it can hardly be employed, for instance, for stitching intestines having a short mesentery.
Another disadvantage of the prior art instrument consists in that it is impossible to achieve an optimal alignment of the layers of the walls of the organs being stitched under varying conditions of surgery, such as the thickness of the walls of the organs being stitched, the state of the organ walls, and the like.
Besides, there are some further disadvantages inherent to the prior art instrument which impose limitations on its use. They are as follows:
since the magazines and dies are insecurely fixed in the initial position, they are likely to fall out of the cylindrical guides while the instrument is being manipulated;
the pushers of the magazines which at the instant of stitching are positioned beneath the organs being stitched are hardly accessible;
it is impossible to apply several anastomoses during an operation without recharging the magazines with staples;
the rotatable magazines and dies are likely to be incorrectly fitted into the guides of the clamp jaws while assembling the instrument, rendering the instrument unusable; and
the fixing toothed plates are likely to be misplaced in the clamp jaws so that the coacting claws of the plates are not directed towards one another, making it impossible to fix the tissues.
The device for mutually aligning the organs to be stitched lengthwise relative to the clamp jaws fails to ensure an adequate accuracy of the alignment of the organ portions being stitched in a longitudinal direction, so that some organ portions remain unstitched. Also, the need to position and clinch the organ portions to be stitched between the clamp jaws by the scales proves a hindrance, since the surgeon has to simultaneously align two edges of the semiperimeters of the organ portions to be stitched, watching both scales.
It is likewise inconvenient to fix the paired jaws of the clamps with the aid of blind holes cooperating with pins, for the blind holes accumulate dirt and are difficult to maintain clean.
The design of the prior art instrument being so sophisticated, it is awkward and heavy and hence difficult to manipulate in the surgery wound. And finally, the prior art instrument is difficult to manufacture.